Contact information
Type
Scientific
Primary contact
Dr Mohgah Elsheikh
ORCID ID
Contact details
Centre for Diabetes & Endocrinology
Melrose House
Royal Berkshire Hospital
London Road
Reading
RG1 5AN
United Kingdom
+44 (0)118 987 7131
mohgah.elsheikh@rbbh-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0199129935
Study information
Scientific title
Acronym
Study hypothesis
Does a low carbohydrate high protein diet enhance weight loss and improve symptoms in women with polycystic ovary syndrome (PCOS)? Assessment of the effects of the low carbohydrate diet on serum androgens and cardiovascular risk factors such as insulin sensitivity and plasma lipids.
Ethics approval
Not provided at time of registration
Study design
Randomised case-controlled prospective study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Nutritional, Metabolic, Endocrine: Polycystic ovarian syndrome (PCOS)
Intervention
Low Carbohydrate Diet vs Low Glycaemic Index Diet
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Weight, body composition, dietary compliance, menstrual cyclicity, ovulation, fasting glucose, insulin and lipids, hirsutism and serum androgens
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/07/2003
Overall trial end date
30/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
60 women with PCOS aged 18-45
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/07/2003
Recruitment end date
30/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Centre for Diabetes & Endocrinology
Reading
RG1 5AN
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Berkshire and Battle Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2008 results published in http://www.endocrine-abstracts.org/ea/0015/ea0015P279.htm